The New Drug Approval Process: Basic Concepts
Recognize the difference between a “drug” and a “new drug” under the Federal Food Drug and Cosmetic Act (FDCA). Learn the various approval pathways for bringing a new drug to the U.S. market. Understand the scientific standards by which FDA will approve a new drug.
Jason F. Conaty, Counsel, Global Regulatory, Hogan Lovells US LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2023.
JASON F. CONATY is a regulatory lawyer at Hogan Lovells US LLP, advising on scientific and regulatory matters in the life sciences and biotechnology area. Concentrating on the development, approval, and marketing of complex therapeutic products, Jason has deep experience on lifecycle management issues relating to drugs, biologics, and drug-device combination products. Before heading to law school, Jason was a bench scientist, working and publishing in the field of nucleic acid chemistry and rational drug design. He completed his PhD in Australia before settling in the United States to take a position at Massachusetts General Hospital, where he was a Fellow of the Leukemia and Lymphoma Society, and a Fellow in Genetics at Harvard Medical School.Get Access
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